1. Field of the Invention
This invention relates generally to medical apparatus and methods, more specifically to instrument immobilizers and even more specifically, but not by way of limitation to an apparatus and methods for anchoring an intracranial probe or lead to the cranium.
Implanting medical devices within the cranium is an increasingly important approach for treatment of disorders such as Parkinson's Disease, essential tremor and dystonia. This approach may also be used to treat a wide array of neuropsychiatric problems, such as depression, epilepsy, obsessive compulsive disorder, obesity and chronic pain. Most of these devices interact with the brain by delivering current through an implanted probe to modulate brain activity. In addition, infusion of drugs through a permanently implanted probe has been proposed as a primary treatment, or as an adjunctive treatment to electrical stimulation, for Alzheimer's and Parkinson's Diseases, among others.
As part of the implant procedure, the probe must be stabilized in the brain. Ideally, any prosthetic device is attached directly to the tissue on which it operates, in this case, the brain. Direct attachment of electrical and chemical probes to brain tissue is impractical. A more easily implementable solution is a system of flexible probes that bend and float with the brain as the brain moves within the cranial cavity. Such probes are secured to the cranium. In this manner, mechanical forces from outside the cranium are prevented from acting on the brain-to-probe interface.
There are a number of current techniques for securing a probe to the cranium. For example, in one approach, a permanently implanted probe is fixed by a sliding door which closes to form a slot just wide enough to slightly compress and grip the body of the probe. A common feature of such devices is that they grip the probe somewhere within the craniotomy opening, and that the slot has a fixed orientation relative to the cranium.
In another approach, the probe passes through a narrow aperture at the center of a craniotomy opening The probe is held in place by a surgeon as it is bent over into a slot leading to the exit from the device. Hinged arms swing into place to narrow the slot and anchor the probe within the slot.
Current anchoring devices are typically positioned over the craniotomy opening, and they are attached to the cranium with several peripheral screws. An implantable lead is placed through the cranial opening and the lead is gripped by two opposing thin bars. In some cases, it is possible to damage the lead by crushing it between the thin bars. It would therefore be desirable to grip the lead with wider bars to more evenly distribute the gripping force over a greater axial length of the implantable lead. It would also be desirable to provide a more stable mounting for the skull-mounted portion of the anchoring device. Additionally, current devices often have a small opening for receiving the lead and thus it would be desirable to provide an anchoring device having a wider opening for the lead, to permit adjustment of lead position for optimal placement, especially when using a large multi-channel probe array, a feature shared by only a few currently available anchoring systems.
2. Description of the Background Art
Prior patents and publications describing anchors for cranial probes include: U.S. Pat. Nos. 4,328,813; 5,464,446; 6,044,304; 2004/0267284; 2005/0192594; and WO 2004/026161.